医院制剂质量标准存在的问题分析及对策探讨  

Problems and Countermeasure Analysis for Hospital Preparation's Quality Standard

作　　者：马佩杰[1] 沈伟 张妍[3] 赵婷[1] 

机构地区：[1]宝鸡市中心医院药剂科,陕西宝鸡721008 [2]陕西省食品药品监督管理局,陕西西安710002 [3]宝鸡市妇幼保健院基层保健科,陕西宝鸡721002

出　　处：《中国医学伦理学》2015年第3期353-355,共3页Chinese Medical Ethics

摘　　要：论述了目前医院制剂普遍存在的质量标准检测方法落后、质量标准缺项严重的问题,并从四个方面对其原因进行了分析,提出了加强药学伦理道德建设;审批部门应严格制剂注册审评技术要求;整顿和提高所有制剂质量标准;加强药学人员引进和培养,积极开展提高质量标准修订工作;医院加大软硬件建设,支持质量标准修订提高工作的建议,为提高医院制剂质量标准提供参考。This paper discusses the current prevalence of hospital preparations backward quality standard test methods, quality standards for lack of a serious problem, and analyses the reasons from four aspects, proposed to strengthen the construction of a pharmaceutical ethics; examination and approval departments shall strictly agents registration review technical requirements ; rectify and improve the quality of all preparation standards ; Introduction and training of strengthen pharmacy personnel, and actively improve the quality standard revision work; hospital in- creasing hardware and software construction, support quality standards revision suggestions for the improvement of work, provide reference standard for quality improvement of hospital preparations.

关 键 词：医院制剂 质量标准 注册审评技术 药学伦理 

分 类 号：R197.32[医药卫生—卫生事业管理]